Three senators have called on the Office of Management and Budget (OMB) to either release its stalled rule on the unique device identification (UDI) system for medical devices or provide a status report, and quickly.
Sens. Herb Kohl (D-Wis.), Chuck Grassley (R-Iowa) and Richard Blumenthal (D-Conn.) wrote Jeffrey Zients, acting director of the Cabinet-level office, last Thursday. They expressed concern over the OMB’s missing of its October 2011 deadline to release the rule, a draft of which the office received three months prior.
“To help us better understand the delay, please provide us with a current comprehensive status report on the UDI rule at OMB,” the senators wrote. “Please include the timeline to when OMB expects to release the UDI rule, whether extensions of review time were granted and causes(s) of the delay. … We respectfully request that OMB provide this information to our offices by no later than close of business on March 1, 2012.”
The letter also reminded Zients that the three senators are the authors of the Medical Device Patient Safety Act introduced last December. As such, they wrote, “We are fully committed to ensuring that FDA has the data it needs to protect the public health, better track problems when device malfunctions occur and improve the recall process of faulty medical devices. Due to our strong desire for a robust post-market environment, we are very concerned with the delayed implementation of the UDI.”
Congress approved the UDI system five years ago as part of the Food and Drug Administration Amendments Act of 2007.